Director of Manufacturing

Job Responsibilities: Own the technical and process side of the CMO relationship: technology transfer, process development, and process validation strategy (IQ/OQ/PQ), ensuring processes are robust, transferable, and audit-readyLead NPI from R&D design handoff through CMO production ramp, translating design intent into manufacturable, CMO-executable work instructions and process specsOwn mfg. process KPIs (yield, scrap, first-pass quality, process capability) and drive corrective action at the process level when performance driftsDrive Lean Manufacturing and Six Sigma initiatives across the CMO network: waste reduction, process capability improvement, and continuous improvement programs at partner sitesPartner with Supply Chain on capacity planning, production scheduling, and single-source risk mitigation, providing the technical input that informs sourcing and dual-sourcing decisionsConduct regular CMO site visits for floor-level process troubleshooting and technology transfer executionPartner closely with the COO on R&D priorities, resourcing, and roadmap executionLead design transfer governance: define the stage-gate criteria a design must meet before release to a CMO for productionServe as the bridge between R&D and manufacturing, resolving design-for-manufacturability issues before they become process nonconformancesFlag process drift or capability concerns at CMO sites to Quality between periodic audits, supporting root cause from the manufacturing/process sideSupport technology transfer and validation documentation that feeds CMO qualification and requalification, which Quality ownsProvide technical/process input into CMO capacity, scheduling, and sourcing decisions owned byCollaborate on single-source risk assessments, contributing the process-transferability view to dual-sourcing decisionsBuild long-term manufacturing strategy as the company scales: when to add CMOs, when to bring select processes in-house, and how to structure the network for growthJob Requirements:10+ years in medical device manufacturing/process engineering, including experience managing production through contract manufacturers rather than owned facilitiesStrong management/leadership experienceTrack record leading CMO technology transfer and process validation at a strategic levelLean Manufacturing and Six Sigma expertise (Green or Black Belt preferred), with demonstrated experience driving process improvement and waste reduction at CMO sitesWorking fluency in ISO 13485 and 21 CFR Part 820/QMSRComfortable operating at both strategic (network strategy, executive reporting) and tactical (protocol review, floor-level CMO troubleshooting) altitudeStrong cross-functional collaborator; this role sits at the intersection of R&D, Quality, and Supply Chain without owning any of those functions outright